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Summary:
This Research Associate-I position will act as a formulation scientist in the development of new or support of existing products. This position will also provide support for formulation/stability testing with Baxter external partners.
Essential Duties and Responsibilities:
Product Development:
- To conduct development trials as per requirement.
- To compile & evaluate the development & stability data.
- To ensure development trails to be performed as per Quality by Design (QBD) approach.
- To prepare the technical documents e.g., Master Formula Record (MFR), Product Development Report (PDR), Product Development Lifecycle Management (PDLM) documents, Protocols & Reports.
- To provide required information for meetings with cross functional teams like Analytical, Regulatory, PSM, Product Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management for on time project delivery.
- To provide required information for meetings with Contract Manufacturing Organizations (CMO), Contract Research Organizations (CRO) & contract Labs for on time project delivery.
- To support the execution of stability batches in Baxter sites & CMOs.
- To support process validation and commercial batches.
- To provide support for successful technology transfer of drug products at manufacturing plant & Contract Manufacturing Sites.
- To review engineering batch & stability batch documents.
- To collect the Stability batch data and review for trending and conduct review of artworks.
- To support sub-department manager to review the technology transfer documents for products developed by CRO & assess the documents which are in-line with QBD based approach & as per current regulatory requirement.
- To perform the required activities for remediation projects to fulfill the regulatory commitments for Out of Specification or Project Change Control Notes or Corrective and Preventive Action or product nature and criticality.
- To perform the required activities to fulfil the regulatory submission & query requirements.
- To prepare the reports to be provided for regulatory response.
- To handle trouble shooting during exhibit and commercial batches with an ability to investigate any Out of Specification (OOS) or Out of Trend (OOT) results.
- To interact with the plant team and impart new product introduction prior to start of production.
- To support External and Internal regulatory audits with respect to Manufacturing Process.
- To support market complaint related activities.
- To possess and be updated on product submission and knowledge in regulatory market, current guidelines i.e. ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), US-FDA (United States Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), EMEA (European Medicines Agency) etc.
- To identify & make available the necessary required resources or infrastructure or instruments to carry-out the day-to-day functions and ensure entire documentation related to formulation development & execution of batch.
- To assist Sub-department Manager & Department Head in investigation for complaints and deviations. To analyze investigation, to suggest any further actions required, to conclude root cause and to seek approval of Corrective and Preventive Action (CAPA) from Department Head.
- To prepare change control and ensure timely closure of the same.
- To ensure compliance related to Lab equipment, instruments, documentation & warehouse.
- To prepare and update SOPs and send for further review of Sub-department Manager & approval of Department Head.
- To document experiments in Electronic Lab Notebook (ELN).
- To identify & request for New Equipment's or instruments for projects in upcoming portfolio & continuous improvement of Development Lab.
- To adopt & follow the Global Quality procedures.
- To identify the safety hazards & perform the Hazard Identification Risk Assessment (HIRA) in coordinates with EHS (Environmental health and safety) practices at place.
Administrative:
- To work collaboratively in cross-functional teams.
- To liaise with customers, staff and suppliers for material procurement or query related or any other work.
- To review the entries in logbooks.
- In the absence of Executive, Sub-department Manager will ensure these roles and responsibilities.
Authorities for rejections or approval:
- To hold the projects due to lack of resources as per guidance by Sub-department Manager.
- To take decision for non-compliance results as per guidance of Sub-department Manager.
Communication to the management / superiors:
- To communicate with sourcing team if any information requires from suppliers.
- To communicate with cross functional team if any information required for product development.
- To communicate about any failure or abnormal notification or non-compliance results to Sub-department Manager & Department Head for their attention and seeking for the solution.
- To communicate project related issues to Sub-department Manager and implement action plan under the guidance of Sub-department Manager.
Qualifications:
- M.S. (Pharm.)/M. Pharm/PhD in Pharmaceutics
- 1 - 8 Years of experience in formulation & development of injectable drug products.
- Writing and computer skills relevant to recording original data as well as creating protocols, reports, and presentations to communicate with partners and team members.
- The ability to energetically attack a problem and synthesize the results into a clear and logical summary in a timely manner is critical.
- Subject matter expertise in areas associated with modern formulation instrumentation. Ability to learn and master new development strategies and develop new methods where appropriate.
- Communication skills to build relationships across functional and geographical boundaries and present technical concepts to technical and non-technical teams.
- Comfort with risk and ambiguity, ability to negotiate critical timelines for analysis in emergency situations.
- Personal responsibility and independent ownership of analysis and results.
- Preferred to have experience with leading large projects and formulation development and technology transfer.
- A good understanding of ICH and cGxP practice.
- Experience in working in global cross-functional teams and project management is a plus.
- Quality oriented.
- Ability to adapt to changes and to work in a team environment as well as delegate effectively to junior team members.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
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